Venoruton 500mg 30 coated tablets

INDICATIONS

VENORUTON is indicated in the treatment of symptoms related to venous insufficiency; states of capillary fragility.

ACTIVE INGREDIENTS

Venoruton 1000 mg powder: One sachet contains - Active ingredient: oxerutin 1000 mg. Venoruton 500 mg coated tablets: One tablet contains: Active ingredient oxerutin 500 mg. Excipients with known effects: sunset yellow aluminum lake (E 110) (2.68 mg/tablet). Venoruton 2% gel: 100 g of gel contains: Active ingredient oxerutin 2 g. Excipients with known effects: benzalkonium chloride 0.05 mg/g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Venoruton 1000 mg powder: mannitol; sodium saccharin; citric acid monohydrate. Venoruton 500 mg coated tablets: polyacrylate dispersion 30 percent; talc; magnesium stearate; macrogoli; copovidone; sunset yellow aluminum lacquer (E 110); titanium dioxide. Venoruton 2% gel for cutaneous use: carbomers; sodium hydroxide; disodium edetate; benzalkonium chloride; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Venoruton 1000 mg powder: 2 to 3 sachets per day, depending on the severity of the symptom. The contents of each sachet of powder should be carefully dissolved in a little water and taken before or during meals, even in venous insufficiency of the hemorrhoidal plexus. Venoruton 500 mg coated tablets: 2 - 3 tablets per day. The tablets should be swallowed whole with a little water, without chewing, before or during meals, even in venous insufficiency of the haemorrhoidal plexus. Venoruton 2% gel for cutaneous use: apply an adequate quantity of gel both on the area affected by the disorder and on the surrounding areas, 2 times a day (morning and evening). Massage lightly to allow the medicine to penetrate until completely absorbed, that is, until the skin feels dry upon contact with your hands. Do not exceed the recommended doses. Use only for short treatment periods.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

Patients suffering from lower limb edema due to heart, kidney or liver disease should not take Venoruton as the effect of Venoruton is not demonstrated in these indications. Pediatric population The use of Venoruton is not recommended in children. Venoruton gel: The use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena. In this case you should stop treatment and contact your doctor to institute suitable therapy. Important information about some excipients Venoruton 1000 mg powder contains: - sodium saccharin: this medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Venoruton 500 mg film-coated tablets contain the azo coloring agent: - sunset yellow aluminum lake (E 110): may cause allergic reactions. Venoruton gel contains: - benzalkonium chloride: this medicinal product contains 0.391 mg of benzalkonium chloride per dose equivalent to 0.05 mg/g. Benzalkonium chloride may irritate the skin. If you are breastfeeding, do not apply this medicine to your breasts because your baby may ingest it with his milk.

INTERACTIONS

To date, no specific interaction of oxerutin with other medicinal products has been reported. In vitro data on a possible modulation of CYP3A activity by oxerutin components (quercetin and rutin present in trace amounts) are conflicting. Venoruton gel: no interactions with medicinal products have been reported.

SIDE EFFECTS

Venoruton oral formulations: Safety profile summary Venoruton may in rare cases cause gastrointestinal side effects or skin reactions such as gastrointestinal disorders, flatulence, diarrhoea, abdominal pain, stomach discomfort, dyspepsia, rash, itching or hives. Very rare is the appearance of dizziness, headache, hot flashes, tiredness or hypersensitivity reactions such as anaphylactoid reactions. Table of adverse reactions Side effects are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1,000); very rare (< 1/10,000), or not known (frequency cannot be estimated from the available data). Within each frequency class, undesirable effects are indicated in order of decreasing seriousness.

Immune system disorders.

Very rare - Adverse reactions: Anaphylactoid reactions.

Very rare - Adverse reactions: Hypersensitivity reactions

Nervous system disorders.

Very rare - Adverse reactions: Dizziness.

Very rare - Adverse reactions: Headache.

Vascular pathologies.

Very rare - Adverse reactions: Flushing.

Gastrointestinal disorders.

Rare - Adverse reactions: Gastrointestinal disorders.

Rare - Adverse reactions: Flatulence.

Rare - Adverse reactions: Diarrhoea.

Rare - Adverse reactions: Abdominal pain.

Rare - Adverse reactions: Stomach disorders.

Rare - Adverse reactions: Dyspepsia.

Pathologies of the skin and subcutaneous tissue.

Rare - Adverse reactions: Rash.

Rare - Adverse reactions: Pruritus.

Rare - Adverse reactions: Urticaria.

Systemic pathologies and conditions relating to the administration site.

Very rare - Adverse reactions: Tiredness.

Venoruton gel: Safety profile summary Venoruton gel is well tolerated. Rare cases of sensitization with the appearance of skin reactions have been observed. These symptoms disappear when treatment is stopped. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

No case of overdose has ever been reported.

PREGNANCY AND BREASTFEEDING

Pregnancy The safety of the drug in pregnancy has not been determined, therefore it is not recommended during pregnancy. Breastfeeding In animal studies, traces of oxerutin have been found in breast milk. It is assumed that the small quantities of oxerutin that pass into breast milk can be considered to have no clinical relevance for humans. Fertility Animal studies have shown no effects on fertility after administration of oxerutin.

EFFECTS ON DRIVING ABILITY

Venoruton has no or negligible influence on the ability to drive or use machines. In rare cases, tiredness and dizziness have been reported in patients taking the product. Affected patients are advised not to drive or use machinery. Venoruton gel does not alter the ability to drive and use machines.